Reynolds Consumer Products Inc.
Richmond, Virginia
Join Reynolds Consumer Products a world of opportunities! We are passionate about achieving results and have fun winning as a team! We are committed to a diverse and inclusive workplace environment in which individual differences are recognized, respected and appreciated. At Reynolds, we provide amazing job opportunities for growth with competitive salaries and benefits in an exciting, dynamic, fast-paced, and fun workplace environment. Are you looking to build a strong career? Then we have an opportunity for you! We currently have an opportunity for a Gluer Crew Member at our manufacturing plant in Richmond, VA. HIRING IMMEDIATELY GREAT PAY! GREAT BENEFITS! GREAT CAREERS! Pay: $19.87 / Hour Your Role: As a Gluer Crew Member you will be responsible for the quality and productivity in the operation of a metal edger, folder/gluer, case packer & palletizer which produces various sizes of cartons with high end graphics on foil/film or plain board. You will have the opportunity to: Safely operate edger, gluing, folding, case-packing machine and logs machine activity. Inspect for quality issues related to carton graphics or structure. Set-up, operate & adjust listed machines. Set-up gluer and maintain log, determine operating conditions, make adjustments and correct malfunctions. May operate hand and fork truck. Perform other Crewmember functions deemed necessary by management. Perform general housekeeping You will love it here if You pay great attention to details You enjoy hands-on work You are looking for an opportunity to grow and advance your career You enjoy a challenge in solving problems What we have to offer you here at Reynolds Wisely Pay Card - so you can get your money fast Comprehensive Benefits Plan (Medical, Dental, and Vision) Wellness Program that pays you back up to $1,000 a year! 401K PTO Tuition Assistance Employee Referral Program earn up to $1,000 Life Insurance Employee Resource Program Paid Parental Leave Adoption Assistance Infertility Coverage Enhanced Musculoskeletal Wellness Program We need you to have: High School Diploma or equivalent Safety - Understand and carry out oral instructions; read and carry out written instructions. Ability to retain and act on oral instructions. Ability to observe and read instruments gauges, dials and make adjustments. Ability to estimate size and quantity of objects. Ability to constantly observe for quality defects as well as subtle problems with machine. Ability to make simple arithmetic calculations. Ability to work with minimal or no supervision. Icing on the cake: Previous manufacturing experience We encourage veterans and individuals from other diverse backgrounds to apply. Want to know more? Check out our website or connect with us on LinkedIn! Apply today to join a fast-growing innovative company! Not a good fit but know someone who is? Please refer them! No relocation assistance is available for this position. Only local candidates will be considered.
Apr 11, 2024
Full time
Join Reynolds Consumer Products a world of opportunities! We are passionate about achieving results and have fun winning as a team! We are committed to a diverse and inclusive workplace environment in which individual differences are recognized, respected and appreciated. At Reynolds, we provide amazing job opportunities for growth with competitive salaries and benefits in an exciting, dynamic, fast-paced, and fun workplace environment. Are you looking to build a strong career? Then we have an opportunity for you! We currently have an opportunity for a Gluer Crew Member at our manufacturing plant in Richmond, VA. HIRING IMMEDIATELY GREAT PAY! GREAT BENEFITS! GREAT CAREERS! Pay: $19.87 / Hour Your Role: As a Gluer Crew Member you will be responsible for the quality and productivity in the operation of a metal edger, folder/gluer, case packer & palletizer which produces various sizes of cartons with high end graphics on foil/film or plain board. You will have the opportunity to: Safely operate edger, gluing, folding, case-packing machine and logs machine activity. Inspect for quality issues related to carton graphics or structure. Set-up, operate & adjust listed machines. Set-up gluer and maintain log, determine operating conditions, make adjustments and correct malfunctions. May operate hand and fork truck. Perform other Crewmember functions deemed necessary by management. Perform general housekeeping You will love it here if You pay great attention to details You enjoy hands-on work You are looking for an opportunity to grow and advance your career You enjoy a challenge in solving problems What we have to offer you here at Reynolds Wisely Pay Card - so you can get your money fast Comprehensive Benefits Plan (Medical, Dental, and Vision) Wellness Program that pays you back up to $1,000 a year! 401K PTO Tuition Assistance Employee Referral Program earn up to $1,000 Life Insurance Employee Resource Program Paid Parental Leave Adoption Assistance Infertility Coverage Enhanced Musculoskeletal Wellness Program We need you to have: High School Diploma or equivalent Safety - Understand and carry out oral instructions; read and carry out written instructions. Ability to retain and act on oral instructions. Ability to observe and read instruments gauges, dials and make adjustments. Ability to estimate size and quantity of objects. Ability to constantly observe for quality defects as well as subtle problems with machine. Ability to make simple arithmetic calculations. Ability to work with minimal or no supervision. Icing on the cake: Previous manufacturing experience We encourage veterans and individuals from other diverse backgrounds to apply. Want to know more? Check out our website or connect with us on LinkedIn! Apply today to join a fast-growing innovative company! Not a good fit but know someone who is? Please refer them! No relocation assistance is available for this position. Only local candidates will be considered.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle. A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Lead and / or participate in complex projects associated with sterility assurance programs. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Lead major deviations for root cause analysis related to sterility assurance programs. Remain abreast of external regulatory requirements associated with sterility assurance programs. Influence revision to corporate guidance associated with sterility assurance programs. Identify and implement continuous improvement for sterility assurance programs. Provide design input related to new processes (e.g., facilities, equipment, etc.) for RTP. Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections. Assists with writing of regulatory submissions for sterility assurance programs. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites. Provide technical mentorship to a less senior scientists within the TS/MS organization. Provide technical mentorship to a less senior cross-functional personnel within RTP. Provide technical consultation across the Parenteral Network. Minimum Requirements: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Minimum 10 years' experience in the biopharmaceutical industry Additional Preferences: Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.) In depth knowledge of risk management and the understanding / ability to use risk assessment tools Ability to analyze complex data and solve problems Strong technical writing and presentation skills Teamwork / interpersonal skills ability to effectively influence Knowledge of microbiology and sterility assurance Other Information: Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required. Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Apr 04, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle. A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Lead and / or participate in complex projects associated with sterility assurance programs. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Lead major deviations for root cause analysis related to sterility assurance programs. Remain abreast of external regulatory requirements associated with sterility assurance programs. Influence revision to corporate guidance associated with sterility assurance programs. Identify and implement continuous improvement for sterility assurance programs. Provide design input related to new processes (e.g., facilities, equipment, etc.) for RTP. Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections. Assists with writing of regulatory submissions for sterility assurance programs. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites. Provide technical mentorship to a less senior scientists within the TS/MS organization. Provide technical mentorship to a less senior cross-functional personnel within RTP. Provide technical consultation across the Parenteral Network. Minimum Requirements: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Minimum 10 years' experience in the biopharmaceutical industry Additional Preferences: Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.) In depth knowledge of risk management and the understanding / ability to use risk assessment tools Ability to analyze complex data and solve problems Strong technical writing and presentation skills Teamwork / interpersonal skills ability to effectively influence Knowledge of microbiology and sterility assurance Other Information: Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required. Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
College Hunks Hauling Junk & Moving - CHHJ NC RALEIGH LLC
Raleigh, North Carolina
Total Compensation: $12.00-$20.00+ per hour which includes hourly rate, tips and performance-based monthly incentives! Note: Previous experience in general labor, loading, unloading, landscaping, construction, production, manufacturing, assembly, or warehouse work is helpful but not required. PART TIME + FULL TIME OPPORTUNITES SCHEDULE: MON-FRIDAY + WEEKENDS AS NEEDED WHAT YOU'LL GET: Competitive Compensation + GREAT TIPS On the spot offers! Weekly new hire orientations mean you can start quickly if desired! Flexible schedules! Full-time, part-time or weekends only available. Hands-on training! We believe in providing you skills, knowledge, and experience that will ensure your success. Career advancement opportunities! There is no other place early in their career that people with little experience can work to build a resume like College Hunks Hauling Junk and Moving! Give back! - We give back to the community by donating two meals to U.S. Hunger for every job we complete. We have donated over 4 MILLION meals! An experience to remember through building leaders in a fun, safe and winning team! WHAT YOU'LL DO: Provide friendly, positive, and stress-free junk removal to all customers. Work hard to safely remove items from clients' homes, offices, and buildings. Be on time. Be friendly. Be safe. Lead by example. Always be branding. WHO WE'RE LOOKING FOR: Must be willing to submit a background check Endurance to lift and carry heavy items (50 lbs. or more) while climbing stairs, balancing, and walking. Eligible to work in the United States Reliable transportation to and from our office Each CHHJ location is independently owned and operated by a franchisee. Your application will go directly to the franchisee, and all hiring decisions will be made by the management of that franchise. All inquiries about employment at this franchise should be made directly to the franchisee, and not to College Hunks Hauling Junk Corporate. EOE.
Apr 18, 2024
Full time
Total Compensation: $12.00-$20.00+ per hour which includes hourly rate, tips and performance-based monthly incentives! Note: Previous experience in general labor, loading, unloading, landscaping, construction, production, manufacturing, assembly, or warehouse work is helpful but not required. PART TIME + FULL TIME OPPORTUNITES SCHEDULE: MON-FRIDAY + WEEKENDS AS NEEDED WHAT YOU'LL GET: Competitive Compensation + GREAT TIPS On the spot offers! Weekly new hire orientations mean you can start quickly if desired! Flexible schedules! Full-time, part-time or weekends only available. Hands-on training! We believe in providing you skills, knowledge, and experience that will ensure your success. Career advancement opportunities! There is no other place early in their career that people with little experience can work to build a resume like College Hunks Hauling Junk and Moving! Give back! - We give back to the community by donating two meals to U.S. Hunger for every job we complete. We have donated over 4 MILLION meals! An experience to remember through building leaders in a fun, safe and winning team! WHAT YOU'LL DO: Provide friendly, positive, and stress-free junk removal to all customers. Work hard to safely remove items from clients' homes, offices, and buildings. Be on time. Be friendly. Be safe. Lead by example. Always be branding. WHO WE'RE LOOKING FOR: Must be willing to submit a background check Endurance to lift and carry heavy items (50 lbs. or more) while climbing stairs, balancing, and walking. Eligible to work in the United States Reliable transportation to and from our office Each CHHJ location is independently owned and operated by a franchisee. Your application will go directly to the franchisee, and all hiring decisions will be made by the management of that franchise. All inquiries about employment at this franchise should be made directly to the franchisee, and not to College Hunks Hauling Junk Corporate. EOE.
Description We are seeking a Lab Technician at our Fresh Kitchen manufacturing plant. Our Fresh Kitchen employs more than 450 associates who assemble a variety of sandwiches, subkits, platters and meals according to Publix's demanding quality standards. These foods are designed to save time for customers! Responsibilities include: performing quality control inspection tasks to include verification of all ingredient and product information performing operational and pre-operational inspections ensuring that each product is manufactured according to FDA regulations including, but not limited to traceability records, temperature monitoring and HACCP records following all safety requirements verifying accuracy of thermometers and product temperatures collecting, processing, packaging, maintaining, and retaining samples for testing providing help to all associates in the Quality Control department and other departments throughout the plant tasting and evaluating all product samples received being cross-trained in Quality Control responsibilities being familiar with all plant functions performing responsibilities accurately from start to finish with completed documentation recording and processing samples received processing and recording customer complaints compliance auditing auditing and updating the plant reference book conducting data entry and ensuring that all products are manufactured under correct procedures from receiving of the raw materials to shipping of the finished product. Additional Information Your application may have additional steps that you will need to complete in order to remain eligible for consideration. Please be sure to monitor your email, including your spam folder, on a daily basis for critical, time-sensitive emails that could require action within 24-48 hours. Please do not use your Publix email address when applying. Once your application has been successfully submitted you will receive a confirmation email. Required Qualifications must be at least 18 years old must be able to work with regulatory inspectors and other compliance officials must be able to work under pressure, be dependable and possess good follow-up skills must demonstrate excellent work habits in line with Good Manufacturing Practices (GMPs) must demonstrate safe working habits must be able to lift in excess of 25 pounds frequently must be able to learn and perform all positions must be able to work in a fast-paced environment must have good human relations skills (the ability to work well with others and be a team player) must be able to work any shift, nights, weekends, holidays, and extended hours must have excellent attendance and punctuality must be willing to assist other team members in other areas must be able to perform steady and productive work for an extended period of time must be able to work efficiently with little or no supervision must be able to follow detailed written and verbal instructions must possess basic math skills must be able to communicate effectively must show enthusiasm, initiative, and pride in work and a commitment to Publix and our mission. Preferred Qualifications working knowledge of Word, Outlook, Access and Excel two year degree in science or related field retail baking experience and lab experience.
Apr 17, 2024
Full time
Description We are seeking a Lab Technician at our Fresh Kitchen manufacturing plant. Our Fresh Kitchen employs more than 450 associates who assemble a variety of sandwiches, subkits, platters and meals according to Publix's demanding quality standards. These foods are designed to save time for customers! Responsibilities include: performing quality control inspection tasks to include verification of all ingredient and product information performing operational and pre-operational inspections ensuring that each product is manufactured according to FDA regulations including, but not limited to traceability records, temperature monitoring and HACCP records following all safety requirements verifying accuracy of thermometers and product temperatures collecting, processing, packaging, maintaining, and retaining samples for testing providing help to all associates in the Quality Control department and other departments throughout the plant tasting and evaluating all product samples received being cross-trained in Quality Control responsibilities being familiar with all plant functions performing responsibilities accurately from start to finish with completed documentation recording and processing samples received processing and recording customer complaints compliance auditing auditing and updating the plant reference book conducting data entry and ensuring that all products are manufactured under correct procedures from receiving of the raw materials to shipping of the finished product. Additional Information Your application may have additional steps that you will need to complete in order to remain eligible for consideration. Please be sure to monitor your email, including your spam folder, on a daily basis for critical, time-sensitive emails that could require action within 24-48 hours. Please do not use your Publix email address when applying. Once your application has been successfully submitted you will receive a confirmation email. Required Qualifications must be at least 18 years old must be able to work with regulatory inspectors and other compliance officials must be able to work under pressure, be dependable and possess good follow-up skills must demonstrate excellent work habits in line with Good Manufacturing Practices (GMPs) must demonstrate safe working habits must be able to lift in excess of 25 pounds frequently must be able to learn and perform all positions must be able to work in a fast-paced environment must have good human relations skills (the ability to work well with others and be a team player) must be able to work any shift, nights, weekends, holidays, and extended hours must have excellent attendance and punctuality must be willing to assist other team members in other areas must be able to perform steady and productive work for an extended period of time must be able to work efficiently with little or no supervision must be able to follow detailed written and verbal instructions must possess basic math skills must be able to communicate effectively must show enthusiasm, initiative, and pride in work and a commitment to Publix and our mission. Preferred Qualifications working knowledge of Word, Outlook, Access and Excel two year degree in science or related field retail baking experience and lab experience.
Company: US6469 Sysco Payroll, Division of Sysco Resources Services, LLC Zip Code: 33823 Minimum Level of Education: High School or Equivalent Minimum Years of Experience: 10+ Years Employment Type: Full Time Travel Percentage: COMPENSATION INFORMATION: The pay range provided is not indicative of Sysco's actual pay range but is merely algorithmic and provided for generalized comparison. Factors that may be used to determine rate of pay include specific skills, work location, work experience and other individualized factors JOB SUMMARY Develop and direct Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company with multiple shift operations or over multiple facilities within a region. Participate with Sysco Specialty Meat Company (SSMC) and/or Sysco Specialty Seafood Company (SSSC) personnel (some companies have combined seafood and meat operations) in the ongoing development, improvement and support of new and existing product quality and FSQA processes including supplier and customer interaction on FSQA matters. The incumbent will manage FSQA execution of source supplier approval, product sourcing functions, produced products, plant sanitation and FSQA related regulatory interaction for the company. RESPONSIBILITIES Develop, lead, direct, update, reassessment, verification and periodic validation of FSQA programs including HACCP Program, Sanitation Standard Operating Procedures, Pest Control, Good Manufacturing Practices, Approved Supplier Program, Foreign Material Control, Plant Sanitation, Chemical Control, Product Quality Assurance, FSQA Customer Complaints, Food Defense and Security Direct Employee Training of FSQA Programs, Policies, and Procedures Direct Recall and Traceability Programs including Mock Recalls Direct Independent FSQA Audit Program - SQF Audits Assist when necessary for product evaluations, plant visits, and supplier/customer communication to assist other staff members. Assist as needed in any manner capable of during emergencies the plant President or General Manager determines are paramount to the business. QUALIFICATIONS Education High school diploma or equivalent; Bachelor's degree in Animal Science, Food Science or Biological Science from four-year college or university Masters degree or higher preferred Experience 5-10 years meat and/or seafood industry (as appropriate) FSQA Management experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate) acceptable instead of a degree. A minimum of three to five years FSQA management with additional R&D(research and development) or production-operations in a meat and/or seafood processing environment being ideal (combined experience preferred). Professional Skills Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Demonstrate the ability to write reports, business correspondence, and procedure manuals, as well as to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Demonstrate the ability to add, subtract, multiply, and divide into all units of measure, using whole numbers, common fractions, and decimals, can compute rate, ratio, and percent and draw and interpret bar graphs. Demonstrate the ability to define problems, collect data, establish facts, and draw valid conclusions. Demonstrate the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to use personal computer, lab equipment, food preparation equipment and office communication equipment. Certifications, Licenses and/or Registrations Valid driver's license. SQF Practitioner or equivalent GFSI scheme experience, Meat and/or Seafood HACCP Certified (as appropriate) Physical Demands Regularly required to talk or hear. Frequently is required to use hands to finger, handle, or feel objects, tools, or controls. Occasionally required to stand; walk; sit; reach with hands and arms; stoop, kneel, crouch, or crawl; and taste or smell. Occasionally lift and/or move up to 100 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Plant audits and inspections may require lifting of products up to 100 pounds and inspection requires working in a production environment on a moving line, lifting cartons, and visual inspection. Corrected vision required for sensory analysis to identify color, clarity. Warehouse and plant audit require close and distance vision to judge GMPs; peripheral vision and depth perception mandatory for safety. Work Environment While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles. Occasionally works near mechanical parts and in high, precarious places and is occasionally exposed to wet and/or humid conditions, extreme cold, and risk of radiation. The noise level in the work environment is usually moderate. Plant audits/inspections and working at remote in-transit processing facilities and Sysco Operating Companies contain both moderate/loud noise and exposure to fumes and mechanical hazards. BENEFITS INFORMATION: For information on Sysco's Benefits, please visit OVERVIEW: Sysco is the global leader in foodservice distribution. With over 71,000 colleagues and a fleet of over 13,000 vehicles, Sysco operates approximately 333 distribution facilities worldwide and serves more than 700,000 customer locations. We offer our colleagues the opportunity to grow personally and professionally, to contribute to the success of a dynamic organization, and to serve others in a manner that exceeds their expectations. We're looking for talented, hard-working individuals to join our team. Come grow with us and let us show you why Sysco is at the heart of food and service. AFFIRMATIVE ACTION STATEMENT: Applicants must be currently authorized to work in the United States. We are proud to be an Equal Opportunity and Affirmative Action employer, and consider qualified applicants without regard to race, color, creed, religion, ancestry, national origin, sex, sexual orientation, gender identity, age, disability, veteran status or any other protected factor under federal, state or local law. This opportunity is available through Sysco Corporation, its subsidiaries and affiliates.
Apr 17, 2024
Full time
Company: US6469 Sysco Payroll, Division of Sysco Resources Services, LLC Zip Code: 33823 Minimum Level of Education: High School or Equivalent Minimum Years of Experience: 10+ Years Employment Type: Full Time Travel Percentage: COMPENSATION INFORMATION: The pay range provided is not indicative of Sysco's actual pay range but is merely algorithmic and provided for generalized comparison. Factors that may be used to determine rate of pay include specific skills, work location, work experience and other individualized factors JOB SUMMARY Develop and direct Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company with multiple shift operations or over multiple facilities within a region. Participate with Sysco Specialty Meat Company (SSMC) and/or Sysco Specialty Seafood Company (SSSC) personnel (some companies have combined seafood and meat operations) in the ongoing development, improvement and support of new and existing product quality and FSQA processes including supplier and customer interaction on FSQA matters. The incumbent will manage FSQA execution of source supplier approval, product sourcing functions, produced products, plant sanitation and FSQA related regulatory interaction for the company. RESPONSIBILITIES Develop, lead, direct, update, reassessment, verification and periodic validation of FSQA programs including HACCP Program, Sanitation Standard Operating Procedures, Pest Control, Good Manufacturing Practices, Approved Supplier Program, Foreign Material Control, Plant Sanitation, Chemical Control, Product Quality Assurance, FSQA Customer Complaints, Food Defense and Security Direct Employee Training of FSQA Programs, Policies, and Procedures Direct Recall and Traceability Programs including Mock Recalls Direct Independent FSQA Audit Program - SQF Audits Assist when necessary for product evaluations, plant visits, and supplier/customer communication to assist other staff members. Assist as needed in any manner capable of during emergencies the plant President or General Manager determines are paramount to the business. QUALIFICATIONS Education High school diploma or equivalent; Bachelor's degree in Animal Science, Food Science or Biological Science from four-year college or university Masters degree or higher preferred Experience 5-10 years meat and/or seafood industry (as appropriate) FSQA Management experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate) acceptable instead of a degree. A minimum of three to five years FSQA management with additional R&D(research and development) or production-operations in a meat and/or seafood processing environment being ideal (combined experience preferred). Professional Skills Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Demonstrate the ability to write reports, business correspondence, and procedure manuals, as well as to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Demonstrate the ability to add, subtract, multiply, and divide into all units of measure, using whole numbers, common fractions, and decimals, can compute rate, ratio, and percent and draw and interpret bar graphs. Demonstrate the ability to define problems, collect data, establish facts, and draw valid conclusions. Demonstrate the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to use personal computer, lab equipment, food preparation equipment and office communication equipment. Certifications, Licenses and/or Registrations Valid driver's license. SQF Practitioner or equivalent GFSI scheme experience, Meat and/or Seafood HACCP Certified (as appropriate) Physical Demands Regularly required to talk or hear. Frequently is required to use hands to finger, handle, or feel objects, tools, or controls. Occasionally required to stand; walk; sit; reach with hands and arms; stoop, kneel, crouch, or crawl; and taste or smell. Occasionally lift and/or move up to 100 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Plant audits and inspections may require lifting of products up to 100 pounds and inspection requires working in a production environment on a moving line, lifting cartons, and visual inspection. Corrected vision required for sensory analysis to identify color, clarity. Warehouse and plant audit require close and distance vision to judge GMPs; peripheral vision and depth perception mandatory for safety. Work Environment While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles. Occasionally works near mechanical parts and in high, precarious places and is occasionally exposed to wet and/or humid conditions, extreme cold, and risk of radiation. The noise level in the work environment is usually moderate. Plant audits/inspections and working at remote in-transit processing facilities and Sysco Operating Companies contain both moderate/loud noise and exposure to fumes and mechanical hazards. BENEFITS INFORMATION: For information on Sysco's Benefits, please visit OVERVIEW: Sysco is the global leader in foodservice distribution. With over 71,000 colleagues and a fleet of over 13,000 vehicles, Sysco operates approximately 333 distribution facilities worldwide and serves more than 700,000 customer locations. We offer our colleagues the opportunity to grow personally and professionally, to contribute to the success of a dynamic organization, and to serve others in a manner that exceeds their expectations. We're looking for talented, hard-working individuals to join our team. Come grow with us and let us show you why Sysco is at the heart of food and service. AFFIRMATIVE ACTION STATEMENT: Applicants must be currently authorized to work in the United States. We are proud to be an Equal Opportunity and Affirmative Action employer, and consider qualified applicants without regard to race, color, creed, religion, ancestry, national origin, sex, sexual orientation, gender identity, age, disability, veteran status or any other protected factor under federal, state or local law. This opportunity is available through Sysco Corporation, its subsidiaries and affiliates.
Company: US6469 Sysco Payroll, Division of Sysco Resources Services, LLC Zip Code: 20785 Minimum Years of Experience: 3 Years Employment Type: Full Time Travel Percentage: 0 Compensation Range: $17.84 - $26.63 The compensation range provided is in compliance with state specific laws. Factors that may be used to determine your actual rate of pay include your specific skills, years of experience and other factors. You may be eligible to participate in the Company's Incentive Plan. BENEFITS INFORMATION: For information on Sysco's Benefits, please visit JOB SUMMARY Monitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company. RESPONSIBILITIES Monitoring of FSQA programs including HACCP Program, sanitation standard operating procedures, pest control, good manufacturing practices, approved supplier program, foreign material control, plant sanitation, chemical control, product quality assurance, FSQA Customer complaints, food defense and security Assist in Employee Training of FSQA Programs, Policies, and Procedures Assist in Implementation of Independent FSQA Audit Program - SQF Audits Assist when necessary for product evaluations, plant visits, and supplier/customer communication to assist other staff members. Assist as needed in any manner capable of during emergencies the plant President or GM (general manager) determines are paramount to the business. Frequently interacts with the following: SSMC/SSSC Personnel, Operations, Sales, Transportation and Maintenance as well as Sysco Operating Companies, and supplier/customer personnel at the line level. QUALIFICATIONS Education Formal job training in TQM principles, SPC, HACCP concepts, CFIA/FDA regulations would be beneficial. Formal quality and sensory analysis training would be helpful. Experience One to 3 years of meat and/or seafood industry (as appropriate) experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate). Raw meat or seafood industry the only experience will be accepted instead of combined experience Professional Skills Demonstrate the ability to write reports, basic business correspondence, as well as to effectively present information and respond to questions from managers. Demonstrate the ability to add, subtract, multiply, and divide into all units of measure, using whole numbers, common fractions, and decimals. Demonstrate the ability to define problems, collect data and establish facts. Demonstrate the ability to interpret basic technical instructions. Ability to use personal computer, lab equipment, food preparation equipment and office communication equipment. Certifications, Licenses and/or Registrations Valid driver's license. Physical Demands Regularly required to talk or hear. Frequently is required to use hands to finger, handle, or feel objects, tools, or controls. Occasionally required to stand; walk; sit; reach with hands and arms; stoop, kneel, crouch, or crawl; and taste or smell. Occasionally lift and/or move up to 100 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Plant audits and inspections may require lifting of products up to 100 pounds and inspection requires working in a production environment on a moving line, lifting cartons, and visual inspection. Corrected vision required for sensory analysis to identify color, clarity. Warehouse and plant audit also requires close and distance vision to judge GMPs; peripheral vision and depth perception mandatory for safety. Work Environment Frequently exposed to fumes or airborne particles. Occasionally works near mechanical parts and in high, precarious places and is occasionally exposed to wet and/or humid conditions, extreme cold, and risk of radiation. The noise level in the work environment is usually moderate and operating in a refrigerated environment is common. Plant audits/inspections and working at remote in-transit processing facilities and Sysco Operating Companies contain both moderate/loud noise and exposure to fumes and mechanical hazards. OVERVIEW: Sysco is the global leader in foodservice distribution. With over 71,000 colleagues and a fleet of over 13,000 vehicles, Sysco operates approximately 333 distribution facilities worldwide and serves more than 700,000 customer locations. We offer our colleagues the opportunity to grow personally and professionally, to contribute to the success of a dynamic organization, and to serve others in a manner that exceeds their expectations. We're looking for talented, hard-working individuals to join our team. Come grow with us and let us show you why Sysco is at the heart of food and service. AFFIRMATIVE ACTION STATEMENT: Applicants must be currently authorized to work in the United States. We are proud to be an Equal Opportunity and Affirmative Action employer, and consider qualified applicants without regard to race, color, creed, religion, ancestry, national origin, sex, sexual orientation, gender identity, age, disability, veteran status or any other protected factor under federal, state or local law. This opportunity is available through Sysco Corporation, its subsidiaries and affiliates.
Apr 17, 2024
Full time
Company: US6469 Sysco Payroll, Division of Sysco Resources Services, LLC Zip Code: 20785 Minimum Years of Experience: 3 Years Employment Type: Full Time Travel Percentage: 0 Compensation Range: $17.84 - $26.63 The compensation range provided is in compliance with state specific laws. Factors that may be used to determine your actual rate of pay include your specific skills, years of experience and other factors. You may be eligible to participate in the Company's Incentive Plan. BENEFITS INFORMATION: For information on Sysco's Benefits, please visit JOB SUMMARY Monitor Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/audit procedures to ensure compliance of products and processes to corporate and regulatory requirements at a Sysco Specialty Meat and/or Seafood Company. RESPONSIBILITIES Monitoring of FSQA programs including HACCP Program, sanitation standard operating procedures, pest control, good manufacturing practices, approved supplier program, foreign material control, plant sanitation, chemical control, product quality assurance, FSQA Customer complaints, food defense and security Assist in Employee Training of FSQA Programs, Policies, and Procedures Assist in Implementation of Independent FSQA Audit Program - SQF Audits Assist when necessary for product evaluations, plant visits, and supplier/customer communication to assist other staff members. Assist as needed in any manner capable of during emergencies the plant President or GM (general manager) determines are paramount to the business. Frequently interacts with the following: SSMC/SSSC Personnel, Operations, Sales, Transportation and Maintenance as well as Sysco Operating Companies, and supplier/customer personnel at the line level. QUALIFICATIONS Education Formal job training in TQM principles, SPC, HACCP concepts, CFIA/FDA regulations would be beneficial. Formal quality and sensory analysis training would be helpful. Experience One to 3 years of meat and/or seafood industry (as appropriate) experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate). Raw meat or seafood industry the only experience will be accepted instead of combined experience Professional Skills Demonstrate the ability to write reports, basic business correspondence, as well as to effectively present information and respond to questions from managers. Demonstrate the ability to add, subtract, multiply, and divide into all units of measure, using whole numbers, common fractions, and decimals. Demonstrate the ability to define problems, collect data and establish facts. Demonstrate the ability to interpret basic technical instructions. Ability to use personal computer, lab equipment, food preparation equipment and office communication equipment. Certifications, Licenses and/or Registrations Valid driver's license. Physical Demands Regularly required to talk or hear. Frequently is required to use hands to finger, handle, or feel objects, tools, or controls. Occasionally required to stand; walk; sit; reach with hands and arms; stoop, kneel, crouch, or crawl; and taste or smell. Occasionally lift and/or move up to 100 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Plant audits and inspections may require lifting of products up to 100 pounds and inspection requires working in a production environment on a moving line, lifting cartons, and visual inspection. Corrected vision required for sensory analysis to identify color, clarity. Warehouse and plant audit also requires close and distance vision to judge GMPs; peripheral vision and depth perception mandatory for safety. Work Environment Frequently exposed to fumes or airborne particles. Occasionally works near mechanical parts and in high, precarious places and is occasionally exposed to wet and/or humid conditions, extreme cold, and risk of radiation. The noise level in the work environment is usually moderate and operating in a refrigerated environment is common. Plant audits/inspections and working at remote in-transit processing facilities and Sysco Operating Companies contain both moderate/loud noise and exposure to fumes and mechanical hazards. OVERVIEW: Sysco is the global leader in foodservice distribution. With over 71,000 colleagues and a fleet of over 13,000 vehicles, Sysco operates approximately 333 distribution facilities worldwide and serves more than 700,000 customer locations. We offer our colleagues the opportunity to grow personally and professionally, to contribute to the success of a dynamic organization, and to serve others in a manner that exceeds their expectations. We're looking for talented, hard-working individuals to join our team. Come grow with us and let us show you why Sysco is at the heart of food and service. AFFIRMATIVE ACTION STATEMENT: Applicants must be currently authorized to work in the United States. We are proud to be an Equal Opportunity and Affirmative Action employer, and consider qualified applicants without regard to race, color, creed, religion, ancestry, national origin, sex, sexual orientation, gender identity, age, disability, veteran status or any other protected factor under federal, state or local law. This opportunity is available through Sysco Corporation, its subsidiaries and affiliates.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description: Provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. Key Objectives/Deliverables Serve as Manufacturing TS/MS representative to work with Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products Leverage prior experience to anticipate commercial manufacturing challenges for new dry products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Serve as the Global Molecule Steward for select oral solid dosage form drug products. Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles. Ensure that experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement in control strategies across sites and technologies. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage prior experience and knowledge as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing. Influence Development on new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of other new technology as appropriate. Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed. Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. Achieve network level results for Lilly's dry products (oral solid dosage forms) that improve the business. Influence global leadership to drive improvements and resolve issues. Basic Requirements: Bachelor's Degree or higher in Chemistry, Engineering, Pharmacy, or related science. Minimum 7-10+ years of direct experience and technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization & commercial GMP-manufacturing. Additional Preferences: Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions. Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines. Ability to lead teams effectively. Demonstrated, strong analytical and problem solving abilities. Effective at integrating multiple technology disciplines to drive programs forward. Flexibility to interact with multiple partners/functions, regions, and cultures. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Apr 14, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Brand Description: Provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. Key Objectives/Deliverables Serve as Manufacturing TS/MS representative to work with Product Development, CM&C teams, Manufacturing sites, and applicable functional areas to commercialize new dry oral solid drug products Leverage prior experience to anticipate commercial manufacturing challenges for new dry products. Work across Development and Manufacturing site(s) to implement appropriate product control strategies based on anticipated needs. Serve as the Global Molecule Steward for select oral solid dosage form drug products. Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness. Provide proficient data analysis and conclusions considering technical, Regulatory and Quality compliance, and business needs. Provide technical leadership for manufacturing process transfers between Lilly and external manufacturing sites as well as additional technical support/guidance for external manufacturing as needed. Drive appropriate shared learning, alignment and improvement across sites and network level activity according to best practices and technical principles. Ensure that experiments and technical work are well designed and appropriately rigorous. Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, and product to improve product/process robustness, reduce variability, and provide improvement in control strategies across sites and technologies. Collaborate with Project Managers on key product project plans and support timely delivery of milestones with appropriate risk mitigation strategies. Leverage prior experience and knowledge as a Subject Matter Expert to collaborate with Development and manufacturing sites in the optimization of key manufacturing platforms such as continuous manufacturing. Influence Development on new product or platform topics in line with Manufacturing needs. Identify and lead the deployment of other new technology as appropriate. Author technical reports and appropriate sections of regulatory submission and responses as needed. Prepare technical aspects of other Regulatory/Quality based documents and support Regulatory reviews and inspections as needed. Remain current on external pharmaceutical manufacturing trends and innovations. Leverage these to improve strategies and applications for developing and controlling manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. As a reviewer of technical reports, provide input on the experimental findings and conclusions. Mentor and provide review/coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. Achieve network level results for Lilly's dry products (oral solid dosage forms) that improve the business. Influence global leadership to drive improvements and resolve issues. Basic Requirements: Bachelor's Degree or higher in Chemistry, Engineering, Pharmacy, or related science. Minimum 7-10+ years of direct experience and technical expertise across multiple areas, unit operations, and platforms related to dry products (oral solid dosage forms) development, commercialization & commercial GMP-manufacturing. Additional Preferences: Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions. Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines. Ability to lead teams effectively. Demonstrated, strong analytical and problem solving abilities. Effective at integrating multiple technology disciplines to drive programs forward. Flexibility to interact with multiple partners/functions, regions, and cultures. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 3+ years of industry related experience in pharmaceuticals in a GMP lab (especially large molecule, small molecule or peptide) Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, and bioassay. Working LC-MS knowledge strongly preferred. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Tasks may require repetitive motion and standing for long periods of time Must be able to lift at least 5 liters of liquid May be required to provide 24 hour cell phone coverage (rare) Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Apr 12, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 3+ years of industry related experience in pharmaceuticals in a GMP lab (especially large molecule, small molecule or peptide) Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, and bioassay. Working LC-MS knowledge strongly preferred. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Tasks may require repetitive motion and standing for long periods of time Must be able to lift at least 5 liters of liquid May be required to provide 24 hour cell phone coverage (rare) Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
This Jobot Job is hosted by: Maria Reyes Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $130,000 per year A bit about us: We are a leading cooperative owned by family farmers across the United States. Committed to delivering wholesome dairy products to consumers globally, our company plays a vital role in supporting sustainable farming practices, innovation, and the dairy industry's growth. As we continue to lead in the production and distribution of high-quality dairy products, we are looking for individuals who share our passion for agriculture, sustainability, and making a positive impact on the world. Why join us? We offer Competitive salaries and benefits! Great PTO Annual bonus & relocation assistance! Job Details Ensure adherence to regulatory requirements and internal FSQ programs/standards. Oversee daily plant Quality and Food Safety operations in alignment with our policies, procedures, customer requirements, and applicable regulations. Take responsibility for the Food Safety and Quality Plans, including supporting prerequisite programs. Enhance and maintain plant policies, procedures, and practices to uphold a cGMP environment. Collaborate cross-functionally to assess and maintain an effective plant hygiene plan. Manage the PEM Program to ensure holistic management of food safety issues and implement effective corrective actions. Supervise plant sanitation to support a robust sanitation program within a cGMP environment. Ensure the effectiveness of plant pest control programs through current, followed, and proactive maintenance. Manage the facility's change control program to enable robust risk assessment and decisions. Lead investigations related to non-conforming events, identifying root causes and implementing effective resolutions. Maintain the CAPA program. Collaborate with R&D during new/reformulated product introductions to ensure compliance with established specifications and regulatory requirements. Act as the point of contact for customer-related issues, complaints, or inquiries. Lead plant complaint investigations, ensuring thorough, effective, timely, and customer-facing responses. Monitor compliance with customer expectations and specifications, communicating any issues or concerns. Maintain plant preparedness for customer and regulatory audits/visits. Provide Leadership: Serve as a key member of the plant leadership team. Collaborate with Operations to foster a world-class food safety and quality culture. Cultivate a positive and effective work culture with direct reports. Identify and retain highly effective personnel through proper selection, training/development, and setting expectations for performance. Track and report on plant quality Key Performance Indicators (KPIs). Participate in the annual plant budgeting process. Collaborate with the plant manager to identify key capital projects supporting food safety and quality initiatives. Provide training to plant personnel concerning food safety, FSMA, and regulatory compliance. Offer quality leadership during unplanned events or emergencies. Provide visible leadership by participating in Gemba walks and internal audits. Engage and interact with all personnel regularly, assisting them with challenges and questions concerning food safety. Bachelor's degree required in Food Science, Biological Sciences or related field 5+ years of experience in food processing environment 3+ years of experience managing teams Prefer experience in dairy manufacturing Certification and/or Licenses HACCP certification SQF Practitioner certified or obtain within first 90 days. PQCI certification Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Apr 11, 2024
Full time
This Jobot Job is hosted by: Maria Reyes Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $130,000 per year A bit about us: We are a leading cooperative owned by family farmers across the United States. Committed to delivering wholesome dairy products to consumers globally, our company plays a vital role in supporting sustainable farming practices, innovation, and the dairy industry's growth. As we continue to lead in the production and distribution of high-quality dairy products, we are looking for individuals who share our passion for agriculture, sustainability, and making a positive impact on the world. Why join us? We offer Competitive salaries and benefits! Great PTO Annual bonus & relocation assistance! Job Details Ensure adherence to regulatory requirements and internal FSQ programs/standards. Oversee daily plant Quality and Food Safety operations in alignment with our policies, procedures, customer requirements, and applicable regulations. Take responsibility for the Food Safety and Quality Plans, including supporting prerequisite programs. Enhance and maintain plant policies, procedures, and practices to uphold a cGMP environment. Collaborate cross-functionally to assess and maintain an effective plant hygiene plan. Manage the PEM Program to ensure holistic management of food safety issues and implement effective corrective actions. Supervise plant sanitation to support a robust sanitation program within a cGMP environment. Ensure the effectiveness of plant pest control programs through current, followed, and proactive maintenance. Manage the facility's change control program to enable robust risk assessment and decisions. Lead investigations related to non-conforming events, identifying root causes and implementing effective resolutions. Maintain the CAPA program. Collaborate with R&D during new/reformulated product introductions to ensure compliance with established specifications and regulatory requirements. Act as the point of contact for customer-related issues, complaints, or inquiries. Lead plant complaint investigations, ensuring thorough, effective, timely, and customer-facing responses. Monitor compliance with customer expectations and specifications, communicating any issues or concerns. Maintain plant preparedness for customer and regulatory audits/visits. Provide Leadership: Serve as a key member of the plant leadership team. Collaborate with Operations to foster a world-class food safety and quality culture. Cultivate a positive and effective work culture with direct reports. Identify and retain highly effective personnel through proper selection, training/development, and setting expectations for performance. Track and report on plant quality Key Performance Indicators (KPIs). Participate in the annual plant budgeting process. Collaborate with the plant manager to identify key capital projects supporting food safety and quality initiatives. Provide training to plant personnel concerning food safety, FSMA, and regulatory compliance. Offer quality leadership during unplanned events or emergencies. Provide visible leadership by participating in Gemba walks and internal audits. Engage and interact with all personnel regularly, assisting them with challenges and questions concerning food safety. Bachelor's degree required in Food Science, Biological Sciences or related field 5+ years of experience in food processing environment 3+ years of experience managing teams Prefer experience in dairy manufacturing Certification and/or Licenses HACCP certification SQF Practitioner certified or obtain within first 90 days. PQCI certification Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Apr 09, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Description: The QA Data Steward within Indianapolis Parenteral Manufacturing is responsible for the creation/verification of Certificates of Analysis for semi-finished and finished commercial batches. In addition, the QA Data Steward is responsible for oversight of critical data maintained within one or more automated system, such as SAP, TrackWise, QualityDocs/Veeva, and Darwin. The QA Data Steward performs impact analyses, ensures all data changes are properly documented and controlled, implements/verifies system changes, and performs system audits, where applicable, to ensure data integrity. Key Objectives/Deliverables: Provide oversight and implement/verify changes of Q-Info Records and Inspection Plans in SAP Provide oversight of the TrackWise system, including the processing of records and performance of system audits, as required Process revisions/creations of QualityDocs/Veeva Specifications, as required, per approved Change Controls and RCM Matrix revisions Process revisions/creations of Darwin product, specification, test allocation, and sampling plan master data records within the Darwin LIMS system Perform timely, accurate impact analyses for changes with impact to SAP, Veeva, and/or Darwin records Create/Verify Certificates of Analysis for semi-finished and finished commercial batches Support projects/initiatives that may impact data stewardship processes and procedures, as needed Minimum Requirements: Experience working in SAP, TrackWise, QualityDocs/Veeva, and/or Darwin Strict attention to detail and ability to maintain compliance issues and meeting critical deadlines. Overall business understanding including proposal of changes, implementation and related regulations; and pharmacopoeia requirements. Excellent written and oral communication skills, troubleshooting and investigating skills, and crisis decision-making skills. Strong organizational skills - ability to handle/prioritize multiple projects and requests. Ability to interact effectively with a variety of people - good teamwork skills. Effective training skills and ability to coach others. Familiarity with cGMPs and corporate policies and procedures. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Additional Preferences: General understanding of laboratory and/or operations techniques and terminology. Previous experience in operations, quality control, and/or regulatory. Proficient in Microsoft Word/Excel/Power Point. Education Requirements: High School Graduate or equivalent. Other Information: Shift schedule: Monday-Friday 8am-5pm Overtime may be required. May be required to support off shift activities related to operational issues. Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position. Minimal travel required May be subject to Post Offer Exam Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Apr 09, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Description: The QA Data Steward within Indianapolis Parenteral Manufacturing is responsible for the creation/verification of Certificates of Analysis for semi-finished and finished commercial batches. In addition, the QA Data Steward is responsible for oversight of critical data maintained within one or more automated system, such as SAP, TrackWise, QualityDocs/Veeva, and Darwin. The QA Data Steward performs impact analyses, ensures all data changes are properly documented and controlled, implements/verifies system changes, and performs system audits, where applicable, to ensure data integrity. Key Objectives/Deliverables: Provide oversight and implement/verify changes of Q-Info Records and Inspection Plans in SAP Provide oversight of the TrackWise system, including the processing of records and performance of system audits, as required Process revisions/creations of QualityDocs/Veeva Specifications, as required, per approved Change Controls and RCM Matrix revisions Process revisions/creations of Darwin product, specification, test allocation, and sampling plan master data records within the Darwin LIMS system Perform timely, accurate impact analyses for changes with impact to SAP, Veeva, and/or Darwin records Create/Verify Certificates of Analysis for semi-finished and finished commercial batches Support projects/initiatives that may impact data stewardship processes and procedures, as needed Minimum Requirements: Experience working in SAP, TrackWise, QualityDocs/Veeva, and/or Darwin Strict attention to detail and ability to maintain compliance issues and meeting critical deadlines. Overall business understanding including proposal of changes, implementation and related regulations; and pharmacopoeia requirements. Excellent written and oral communication skills, troubleshooting and investigating skills, and crisis decision-making skills. Strong organizational skills - ability to handle/prioritize multiple projects and requests. Ability to interact effectively with a variety of people - good teamwork skills. Effective training skills and ability to coach others. Familiarity with cGMPs and corporate policies and procedures. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Additional Preferences: General understanding of laboratory and/or operations techniques and terminology. Previous experience in operations, quality control, and/or regulatory. Proficient in Microsoft Word/Excel/Power Point. Education Requirements: High School Graduate or equivalent. Other Information: Shift schedule: Monday-Friday 8am-5pm Overtime may be required. May be required to support off shift activities related to operational issues. Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position. Minimal travel required May be subject to Post Offer Exam Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
27946BR Position Title: Lab Technician, Overnight, Fresh Kitchen - Lakeland Department: Lakeland Kitchen Location: Lakeland, FL Description: We are seeking a Lab Technician at our Fresh Kitchen manufacturing plant. Our Fresh Kitchen employs more than 450 associates who assemble a variety of sandwiches, subkits, platters and meals according to Publix's demanding quality standards. These foods are designed to save time for customers! Responsibilities include: + performing quality control inspection tasks to include verification of all ingredient and product information + performing operational and pre-operational inspections + ensuring that each product is manufactured according to FDA regulations including, but not limited to traceability records, temperature monitoring and HACCP records + following all safety requirements + verifying accuracy of thermometers and product temperatures + collecting, processing, packaging, maintaining, and retaining samples for testing + providing help to all associates in the Quality Control department and other departments throughout the plant + tasting and evaluating all product samples received + being cross-trained in Quality Control responsibilities + being familiar with all plant functions + performing responsibilities accurately from start to finish with completed documentation + recording and processing samples received + processing and recording customer complaints + compliance auditing + auditing and updating the plant reference book + conducting data entry and + ensuring that all products are manufactured under correct procedures from receiving of the raw materials to shipping of the finished product. Req ID: 27946BR Hours of Work: 5:00pm - 3:30am; Rotating days State: Florida Frequency of Pay: Weekly Travel Frequency: 0% Minimum Base Pay: 18.90 Additional Information: Your application may have additional steps that you will need to complete in order to remain eligible for consideration. Please be sure to monitor your email, including your spam folder, on a daily basis for critical, time-sensitive emails that could require action within 24-48 hours. Please do not use your Publix email address when applying. Once your application has been successfully submitted you will receive a confirmation email. Address: 3045 New Tampa Hwy City: Lakeland Other Compensation Information: Weekend Differential: A $2.00 per hour weekend differential is paid to associates for hours worked between 12:00 a.m. Saturday through 11:59 p.m. Sunday. Night Differential: A $.75 per hour night differential is paid to associates regularly scheduled to work any hours between midnight and 3:00 a.m. Year End Bonus: To reward associates for their contributions to the company for the calendar year, Publix provides a Holiday Bonus in November. In the first year of continuous employment the bonus is equal to 15 hours of pay, and in the second year of continuous employment the bonus is equal to one week's pay if associate remains employed through issue date of the bonus check. In subsequent years, the bonus is equal to two weeks' pay. Maximum Base Pay: 26.10 Required Qualifications: + must be at least 18 years old + must be able to work with regulatory inspectors and other compliance officials + must be able to work under pressure, be dependable and possess good follow-up skills + must demonstrate excellent work habits in line with Good Manufacturing Practices (GMPs) + must demonstrate safe working habits + must be able to lift in excess of 25 pounds frequently + must be able to learn and perform all positions + must be able to work in a fast-paced environment + must have good human relations skills (the ability to work well with others and be a team player) + must be able to work any shift, nights, weekends, holidays, and extended hours + must have excellent attendance and punctuality + must be willing to assist other team members in other areas + must be able to perform steady and productive work for an extended period of time + must be able to work efficiently with little or no supervision + must be able to follow detailed written and verbal instructions + must possess basic math skills + must be able to communicate effectively + must show enthusiasm, initiative, and pride in work and + a commitment to Publix and our mission. Preferred Qualifications: + working knowledge of Word, Outlook, Access and Excel + two year degree in science or related field + retail baking experience and + lab experience. Potential Annual Base Pay: 39,312 - 54,288 Zip Code: Work Environment: Temperatures range from 0 to 90+ degrees. Benefits Information: + Employee stock ownership plan that contributes Publix stock to associates each year at no cost + An opportunity to purchase additional shares of our privately-held stock + 401(k) retirement savings plan + Group health, dental and vision plans + Paid Time Off + Paid Parental Leave + Short- and long-term disability insurance + Tuition reimbursement + Free hot lunches (buffet-style) at facilities with a cafeteria + Visit our website to see all of our benefits: Benefits - Jobs () ()
Apr 04, 2024
Full time
27946BR Position Title: Lab Technician, Overnight, Fresh Kitchen - Lakeland Department: Lakeland Kitchen Location: Lakeland, FL Description: We are seeking a Lab Technician at our Fresh Kitchen manufacturing plant. Our Fresh Kitchen employs more than 450 associates who assemble a variety of sandwiches, subkits, platters and meals according to Publix's demanding quality standards. These foods are designed to save time for customers! Responsibilities include: + performing quality control inspection tasks to include verification of all ingredient and product information + performing operational and pre-operational inspections + ensuring that each product is manufactured according to FDA regulations including, but not limited to traceability records, temperature monitoring and HACCP records + following all safety requirements + verifying accuracy of thermometers and product temperatures + collecting, processing, packaging, maintaining, and retaining samples for testing + providing help to all associates in the Quality Control department and other departments throughout the plant + tasting and evaluating all product samples received + being cross-trained in Quality Control responsibilities + being familiar with all plant functions + performing responsibilities accurately from start to finish with completed documentation + recording and processing samples received + processing and recording customer complaints + compliance auditing + auditing and updating the plant reference book + conducting data entry and + ensuring that all products are manufactured under correct procedures from receiving of the raw materials to shipping of the finished product. Req ID: 27946BR Hours of Work: 5:00pm - 3:30am; Rotating days State: Florida Frequency of Pay: Weekly Travel Frequency: 0% Minimum Base Pay: 18.90 Additional Information: Your application may have additional steps that you will need to complete in order to remain eligible for consideration. Please be sure to monitor your email, including your spam folder, on a daily basis for critical, time-sensitive emails that could require action within 24-48 hours. Please do not use your Publix email address when applying. Once your application has been successfully submitted you will receive a confirmation email. Address: 3045 New Tampa Hwy City: Lakeland Other Compensation Information: Weekend Differential: A $2.00 per hour weekend differential is paid to associates for hours worked between 12:00 a.m. Saturday through 11:59 p.m. Sunday. Night Differential: A $.75 per hour night differential is paid to associates regularly scheduled to work any hours between midnight and 3:00 a.m. Year End Bonus: To reward associates for their contributions to the company for the calendar year, Publix provides a Holiday Bonus in November. In the first year of continuous employment the bonus is equal to 15 hours of pay, and in the second year of continuous employment the bonus is equal to one week's pay if associate remains employed through issue date of the bonus check. In subsequent years, the bonus is equal to two weeks' pay. Maximum Base Pay: 26.10 Required Qualifications: + must be at least 18 years old + must be able to work with regulatory inspectors and other compliance officials + must be able to work under pressure, be dependable and possess good follow-up skills + must demonstrate excellent work habits in line with Good Manufacturing Practices (GMPs) + must demonstrate safe working habits + must be able to lift in excess of 25 pounds frequently + must be able to learn and perform all positions + must be able to work in a fast-paced environment + must have good human relations skills (the ability to work well with others and be a team player) + must be able to work any shift, nights, weekends, holidays, and extended hours + must have excellent attendance and punctuality + must be willing to assist other team members in other areas + must be able to perform steady and productive work for an extended period of time + must be able to work efficiently with little or no supervision + must be able to follow detailed written and verbal instructions + must possess basic math skills + must be able to communicate effectively + must show enthusiasm, initiative, and pride in work and + a commitment to Publix and our mission. Preferred Qualifications: + working knowledge of Word, Outlook, Access and Excel + two year degree in science or related field + retail baking experience and + lab experience. Potential Annual Base Pay: 39,312 - 54,288 Zip Code: Work Environment: Temperatures range from 0 to 90+ degrees. Benefits Information: + Employee stock ownership plan that contributes Publix stock to associates each year at no cost + An opportunity to purchase additional shares of our privately-held stock + 401(k) retirement savings plan + Group health, dental and vision plans + Paid Time Off + Paid Parental Leave + Short- and long-term disability insurance + Tuition reimbursement + Free hot lunches (buffet-style) at facilities with a cafeteria + Visit our website to see all of our benefits: Benefits - Jobs () ()
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 5+ years of industry related experience in pharmaceuticals in a GMP lab must have experience with mAbs Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, CE-R, CE-NR, iCief and bioassay. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Tasks may require repetitive motion and standing for long periods of time Must be able to lift at least 5 liters of liquid May be required to provide 24 hour cell phone coverage (rare) Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Apr 01, 2024
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical position helping to ensure that the analytical testing of products at multiple sites meets both Lilly and external requirements and is executed consistently to predetermined standards. The Analytical Technical Steward reviews data released by contract manufacturers according to API EM Risk Based Oversight Governance to ensure it meets internal integration and data integrity expectations, reviews deviations for trends, reviews and/or releases stability data, and leads resolution of laboratory related manufacturing issues by performing in-depth problem solving, proactively identifying opportunities for continuous improvement, and completing thorough investigations of aberrant data and results. They may perform non-routine lab work in support of this. Additionally, the Analytical Technical Steward represents the quality laboratories on cross-functional internal and joint process teams. The Analytical Technical Steward works closely with development counterparts and GQL (Global Quality Laboratories) to ensure robust analytical control strategies are established for molecules they support. Responsibilities: Technical review, interpretation, and release of data including data released from CM (Contract Manufacturers), stability, process validation, and reference standard characterization. Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. Develop investigational testing protocols and perform testing as required. Contribute to APR, tech transfer, and process validation as required. Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners. Participate in internal/external audits as needed. Develop and ensure execution of quality plan projects. Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing. Performs method assessments, with deficiencies and areas for improvement noted within the assessments. Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed. Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices). Review of analytical test method packages. Approval of test method protocols. Approval of new test methods or changes or deletions to existing test methods. Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions). Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies. Improve assays in QC. These improvements include variability reduction, method optimization, and new method development. Local and Global Method Change Control Ownership. Oversight of reference standard evaluations per Global Quality Standards. Selection of appropriate packaging materials. Consult in the preparation of the characterization protocol for corporate reference standards. Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards. Participate in the review of the reference standard profile and associated documentation for data integrity. Method transfers to Contract Manufacturers. Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs. Monograph review and implementation. Ensures consistent practices between laboratories running the same methods. Effective management of multiple projects. Basic Requirements: Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy) 5+ years of industry related experience in pharmaceuticals in a GMP lab must have experience with mAbs Additional Skills/Preferences: Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, CE-R, CE-NR, iCief and bioassay. Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines. Deep understanding of compliance requirements and regulatory expectations. Demonstrated accuracy and proficiency in analytical skills. Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology. Strong oral and written communication skills demonstrated through documentation and presentations. Demonstrated strong interpersonal interaction skills. Ability to work in cross functional teams as well as across networks. Demonstrated analytical skills. Demonstrated experience with method qualification, validation, and transfer. Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include small molecules, monoclonal antibodies, synthetic peptides, and E. coli platform large molecules. Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV). Proven ability to support maintenance of Corporate Reference Standards and manage testing and reporting of results from contract manufacturers. Additional Information: Tasks may require repetitive motion and standing for long periods of time Must be able to lift at least 5 liters of liquid May be required to provide 24 hour cell phone coverage (rare) Position will be day shift, but may require some shift to support global operations May require up to approximately 20% of travel overseas, passport required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Business Unit Overview Headquartered in Lakeville, Minn., Post Consumer Brands, a business unit of Post Holdings, Inc., is dedicated to providing people and their pets with delicious food choices for every taste and budget. The company's portfolio includes beloved brands such as Honey Bunches of Oats, PEBBLES, Grape-Nuts and Malt-O-Meal cereal, and Peter Pan peanut butter, as well as Rachael Ray Nutrish, Kibbles 'n Bits and 9Lives dog and cat food. As a company committed to high standards of quality and to our values, we are driven by one idea: To make lives better by making delicious food accessible for all. For more information about our brands, visit and follow us on LinkedIn for the latest news. Brand Post Consumer Brands recently acquired several iconic pet food brands, venturing into a new market while remaining true to our purpose to provide delicious and accessible food that our consumers love. We're always searching the center store for the next exciting product to add to our portfolio, and right now, we're growing and need passionate, driven individuals with diverse perspectives to help us reach greater heights. That's where you come in. Join a team where your voice is not only heard but valued. Make a real impact on brands enjoyed by millions of people and their pets. At Post Consumer Brands, we take pride in our longstanding legacy of making one of every five breakfast cereals families eat daily. Today, we're just as focused on our future as we expand our grocery business with different shelf-stable foods, including snacks and peanut butter. We are committed to providing accessible and delicious food for families, and we're always searching the center store for the next exciting product to add to our portfolio. As we soar to new heights, we need creative, determined individuals from all walks of life to join our team, where your unique perspective and ideas are acknowledged and valued. Be a part of a company that empowers you to make a difference that's evident on grocery store shelves and families' tables across North America. Location Description Post Consumer Brands in Jonesboro, Ark. is home to more than 200 team members. Jonesboro may be a smaller town, but it has a strong performing arts scene, multiple schools, and a diverse geography with sports and outdoor recreation opportunities for everyone. The Post Jonesboro team supports the community through food pantry volunteering and an annual toy drive during the holiday season. Responsibilities Schedule: This position works a 2-2-3 (12 hour) shift schedule starting from 6:00 pm to 6:00 am. This position works every other weekend. Education: 4-year college degree or equivalent experience REQUIRED. Degree in chemistry, microbiology, math, statistics or food science strongly preferred. Post Consumer Brands has tuition reimbursement available to support this education as well! Experience: 3 years of food production and lab experience is a must. JOB SUMMARY The purpose of this position is to provide real-time technical support to the Operations Teams and other support staff assigned. The individual is responsible for providing Operations Teams and Supervisors with the necessary information to produce products that meet PCBs food safety and quality standards at the lowest cost in a timely manner. The individual plays a key role in assisting in the identification, investigation, and follow up activities of PCB continuous improvement program. Support, implement, and maintain food safety practices as required through SQF. Will be responsible for completing job duties in a manner that supports all plant safety, food safety, quality, and environmental practices. ACTIVITIES/DUTIES Provide Operations Team Members, management, and Maintenance with technical resources in areas of product quality and food safety during on-going production, as well as in noncompliance situations. Attend noncompliance meetings to give direction on immediate actions, root cause investigation, product disposition, and any necessary corrective actions. Perform audits and analyses on finished and intermediate products, ingredients, packaging, and systems and follow safety, sanitation, Good Manufacturing Practices, and Good Laboratory Practices while performing tests Conduct investigations into consumer and customer complaints. Perform, record and report audit findings in areas of Pest Prevention, Sanitation, GMP's, Pre-Op Inspection/Testing, Plant Environment, HACCP, SSOP's, Net Weight, PSAs, Metal Detection Audit, Documentation Audit, Allergen Testing, and Ingredient COA Verification. Calibration and maintenance of Quality measurement equipment in production and in the QA Lab. Provide information and data to support the QA group in assigned project areas. Use databases to hold and release product, provide non-compliance ingredient and packaging information to vendors (SCAR's), and report and store audit reports. Utilize the Quality Department resources to help in the identification and resolution of issues. Additional duties as required by Management to meet the food-safety needs of the facility. Schedule: This position works a 2-2-3 (12 hour) shift schedule starting from 6:00 pm to 6:00 am. This position works every other weekend. Qualifications Education: 4-year college degree or equivalent experience in chemistry, microbiology, math, statistics or food science strongly preferred. Post Consumer Brands has tuition reimbursement available to support this education as well! Experience: 3 years of food production and lab experience is a must. Knowledge, Skills, Abilities, and Other Competencies: Knowledge of manufacturing processes, GMP's, food safety, GLP's, statistics and lab techniques preferred Experience in Food Systems, audit experience, with PCQI certification preferred. Excellent organizational and problem solving skills Math/statistical computation skills Knowledge of SPC Ability to work safely with chemicals and near equipment Ability to compile, analyze and present collected data in summary form as well as being capable of performing a variety of tests Ability to communicate technical, scientific, and regulatory information, both written and verbally Ability to make presentations, facilitate meetings, probe for root cause, and provide training to various groups within the organization Knowledge of quality problem solving tools Must be able to read, write and communicate in the English language
Mar 28, 2024
Full time
Business Unit Overview Headquartered in Lakeville, Minn., Post Consumer Brands, a business unit of Post Holdings, Inc., is dedicated to providing people and their pets with delicious food choices for every taste and budget. The company's portfolio includes beloved brands such as Honey Bunches of Oats, PEBBLES, Grape-Nuts and Malt-O-Meal cereal, and Peter Pan peanut butter, as well as Rachael Ray Nutrish, Kibbles 'n Bits and 9Lives dog and cat food. As a company committed to high standards of quality and to our values, we are driven by one idea: To make lives better by making delicious food accessible for all. For more information about our brands, visit and follow us on LinkedIn for the latest news. Brand Post Consumer Brands recently acquired several iconic pet food brands, venturing into a new market while remaining true to our purpose to provide delicious and accessible food that our consumers love. We're always searching the center store for the next exciting product to add to our portfolio, and right now, we're growing and need passionate, driven individuals with diverse perspectives to help us reach greater heights. That's where you come in. Join a team where your voice is not only heard but valued. Make a real impact on brands enjoyed by millions of people and their pets. At Post Consumer Brands, we take pride in our longstanding legacy of making one of every five breakfast cereals families eat daily. Today, we're just as focused on our future as we expand our grocery business with different shelf-stable foods, including snacks and peanut butter. We are committed to providing accessible and delicious food for families, and we're always searching the center store for the next exciting product to add to our portfolio. As we soar to new heights, we need creative, determined individuals from all walks of life to join our team, where your unique perspective and ideas are acknowledged and valued. Be a part of a company that empowers you to make a difference that's evident on grocery store shelves and families' tables across North America. Location Description Post Consumer Brands in Jonesboro, Ark. is home to more than 200 team members. Jonesboro may be a smaller town, but it has a strong performing arts scene, multiple schools, and a diverse geography with sports and outdoor recreation opportunities for everyone. The Post Jonesboro team supports the community through food pantry volunteering and an annual toy drive during the holiday season. Responsibilities Schedule: This position works a 2-2-3 (12 hour) shift schedule starting from 6:00 pm to 6:00 am. This position works every other weekend. Education: 4-year college degree or equivalent experience REQUIRED. Degree in chemistry, microbiology, math, statistics or food science strongly preferred. Post Consumer Brands has tuition reimbursement available to support this education as well! Experience: 3 years of food production and lab experience is a must. JOB SUMMARY The purpose of this position is to provide real-time technical support to the Operations Teams and other support staff assigned. The individual is responsible for providing Operations Teams and Supervisors with the necessary information to produce products that meet PCBs food safety and quality standards at the lowest cost in a timely manner. The individual plays a key role in assisting in the identification, investigation, and follow up activities of PCB continuous improvement program. Support, implement, and maintain food safety practices as required through SQF. Will be responsible for completing job duties in a manner that supports all plant safety, food safety, quality, and environmental practices. ACTIVITIES/DUTIES Provide Operations Team Members, management, and Maintenance with technical resources in areas of product quality and food safety during on-going production, as well as in noncompliance situations. Attend noncompliance meetings to give direction on immediate actions, root cause investigation, product disposition, and any necessary corrective actions. Perform audits and analyses on finished and intermediate products, ingredients, packaging, and systems and follow safety, sanitation, Good Manufacturing Practices, and Good Laboratory Practices while performing tests Conduct investigations into consumer and customer complaints. Perform, record and report audit findings in areas of Pest Prevention, Sanitation, GMP's, Pre-Op Inspection/Testing, Plant Environment, HACCP, SSOP's, Net Weight, PSAs, Metal Detection Audit, Documentation Audit, Allergen Testing, and Ingredient COA Verification. Calibration and maintenance of Quality measurement equipment in production and in the QA Lab. Provide information and data to support the QA group in assigned project areas. Use databases to hold and release product, provide non-compliance ingredient and packaging information to vendors (SCAR's), and report and store audit reports. Utilize the Quality Department resources to help in the identification and resolution of issues. Additional duties as required by Management to meet the food-safety needs of the facility. Schedule: This position works a 2-2-3 (12 hour) shift schedule starting from 6:00 pm to 6:00 am. This position works every other weekend. Qualifications Education: 4-year college degree or equivalent experience in chemistry, microbiology, math, statistics or food science strongly preferred. Post Consumer Brands has tuition reimbursement available to support this education as well! Experience: 3 years of food production and lab experience is a must. Knowledge, Skills, Abilities, and Other Competencies: Knowledge of manufacturing processes, GMP's, food safety, GLP's, statistics and lab techniques preferred Experience in Food Systems, audit experience, with PCQI certification preferred. Excellent organizational and problem solving skills Math/statistical computation skills Knowledge of SPC Ability to work safely with chemicals and near equipment Ability to compile, analyze and present collected data in summary form as well as being capable of performing a variety of tests Ability to communicate technical, scientific, and regulatory information, both written and verbally Ability to make presentations, facilitate meetings, probe for root cause, and provide training to various groups within the organization Knowledge of quality problem solving tools Must be able to read, write and communicate in the English language